New OIVD Director Says FDA May Need To Go Back To 'Square One' on IVDMIA Guidance

OIVD Director Alberto Gutierrez acknowledged that the dual regulatory pathway — through CMS under the Clinical Laboratory Improvement Amendments and through the FDA — creates "an uneven playing field" for diagnostics developers.

Full-text access for premium subscribers only. Existing premium subscribers login here.
New to GenomeWeb? Register here quickly.